The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-397-2013·Announced 2013-05-22

Green Valley Drugs Recalls Nandrolone Decanoate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Nandrolone Decanoate Injection because the pharmacy could not ensure the sterility of the compounded products.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Nandrolone Decanoate Injection in all strengths and presentations. The affected products include Nandrolone Decanoate 300 mg/mL, Nandrolone 200 mg/mL, Nandrolone 250 mg/mL, and Nandrolone 350 mg/mL. The recall involves 43 vials distributed nationwide.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes at the facility.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Sterile Injection
Hazard
Affected units
43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: a) Nandrolone Decanoate 300 mg/mL: 20130311-J
  • Exp 6/11/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 78 products in this recall →

Related recalls

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

See all →

Same hazard · sterility

See all →

Similar recalls